Blood PressureNCT01019499
The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
A study testing berry products in people with Blood Pressure and Platelet Function, run by Finnish Institute for Health and Welfare at 2 sites in Finland.
Trial summary
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Platelet Function, Inflammation
- What is being tested?
- berry products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesFinland
- Study dates
- Feb 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)
Who cannot join
- smoking
- regular use of medications (except hormone replacement therapy) or dietary supplements
- intestinal disorders
- obesity (BMI> 35 kg/m2)
- vegetarianism
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
National Institute for Health and Welfare
Helsinki, Helsinki, 00300
National Institute for Health and Welfare
Turku, Turku, 20720
About this study
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).
Read the detailed description
The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.
- Conditions
- Blood Pressure, Platelet Function, Inflammation
- Being tested
- berry products, control products
- Keywords
- human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berry productsOther
effects of berry consumption on cardiovascular indicators
two portions daily
control productsOther
two portions daily
| Study group | Role | What they receive |
|---|---|---|
| berry products | Active comparator | Berry products Receives: Other: berry products |
| control products | Placebo comparator | Control products Receives: Other: control products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 0, 8 and 16 weeks
Secondary outcomes (2)
PFA-100 measurement
Measured: 0, 8 and 16 weeks
biomarkers of cardiovascular disease risk
Measured: 0, 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Agrifood Research Finland, The Finnish Funding Agency for Technology and Innovation, Academy of Finland, University of Oslo
- Investigators
- Antti Jula, DR., Study director, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019499
- Sponsor's protocol ID
- NPHIKTL
- Status last verified
- Jun 2010
- First submitted
- 24 Nov 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01019499
- Acronym / sponsor ID
- NPHIKTL
- Conditions
- Blood Pressure, Platelet Function, Inflammation
- Keywords
- human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Agrifood Research Finland, The Finnish Funding Agency for Technology and Innovation, Academy of Finland, University of Oslo
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).
Detailed description
The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berry products | Active comparator | Other: berry productsBerry products |
| control products | Placebo comparator | Other: control productsControl products |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)
Key exclusion criteria (6 listed)
- smoking
- regular use of medications (except hormone replacement therapy) or dietary supplements
- intestinal disorders
- obesity (BMI> 35 kg/m2)
- vegetarianism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| berry productseffects of berry consumption on cardiovascular indicators two portions daily | Other | berry products |
| control productstwo portions daily | Other | control products |
Primary outcome
Blood pressure
Time frame: 0, 8 and 16 weeks
2 secondary outcomes
PFA-100 measurement
Time frame: 0, 8 and 16 weeks
biomarkers of cardiovascular disease risk
Time frame: 0, 8 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti Jula, DR. study director
Finnish Institute for Health and Welfare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing berry products in people with Blood Pressure and Platelet Function, run by Finnish Institute for Health and Welfare at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 0, 8 and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.